Tag Archives: denis devos

Work Instructions and Audits

Question Regarding ISO 9001: 2008 (or 2015) auditing, I have always been trained that a work instruction when implemented as supporting the QMS can be audited as it is supporting the effectiveness of the QMS. I was recently told by … Continue reading

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Verification or Calibration?

Question There is a second part to 7.6 para “a” which reads; “where no such standards exist, the basis used for calibration or verification shall be recorded.” It is clear for shops that are complying to the ISO 9001:2008(E) we … Continue reading

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Clauses 8.4.1 and 8.4.2 in 9001

Question The insurance company I am temporarily helping on quality is limiting its ISO 9001 certified perimeter to the administration of contracts and claims. With regard to clauses 8.4.1 and particularly 8.4.2 of ISO 9001:2015, should the other internal entities … Continue reading

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“Shall Be Determined” in 9001

Question Many of the Quality Management Systems requirements in the ISO 9001: 2015 manual include the verbiage “shall be determined.”  I need to be sure that I understand exactly what this means in this context.  For example, “4.4  QMS and … Continue reading

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Customer Satisfaction

Question The question is about 9.3.2.1 in IATF 16949. It said the input to management review shall include (f) customer satisfaction. Because that clause is supplemental to ISO 9001, 9.3.2, where C (1) customer satisfaction and feedback from relevant interested … Continue reading

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Creating a Culture of Quality

Question I was introduced to Quality Management (& ISO 9001:2015) recently. The culture of the organization that I am concerned with has not embraced Quality Management, and it is often the subject of outright and unprofessional antagonism. I seek direction … Continue reading

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Audit Versus Inspection?

Question Would you please tell me what the differences between audit and inspection are? Answer This is a great question.   We can start with the definitions of inspection and audit per the new ISO 9000:2015 standard.  Inspection is “Determination of … Continue reading

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